KMID : 0338420230380040504
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The Korean Journal of Internal Medicine 2023 Volume.38 No. 4 p.504 ~ p.513
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Efficacy and safety of sofosbuvir?velpatasvir and sofosbuvir?velpatasvir?voxilaprevir for hepatitis C in Korea: a Phase 3b study
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Heo Jeong
Kim Yoon-Jun Lee Sung-Wook Lee Youn-Jae Yoon Ki-Tae Byun Kwan-Soo Jung Yong-Jin Tak Won-Young Jeong Sook-Hyang Kwon Kyung-Min Vithika Suri Peiwen Wu Jang Byoung-Kuk Lee Byung-Seok Cho Ju-Yeon Jang Jeong-Won Yang Soo-Hyun Paik Seung-Woon Kim Hyung-Joon Kwon Jung-Hyun Park Neung-Hwa Kim Ju-Hyun Kim In-Hee Ahn Sang-Hoon Lim Young-Suk
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Abstract
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Background/Aims: Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir?velpatasvir and sofosbuvir?velpatasvir?voxilaprevir for 12 weeks in HCV-infected Korean adults.
Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir?velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ¡Ã 4 weeks received sofosbuvir?velpatasvir?voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment.
Results: Of 53 participants receiving sofosbuvir?velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir?velpatasvir?voxilaprevir achieved SVR 12. Overall, sofosbuvir?velpatasvir and sofosbuvir?velpatasvir?voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported.
Conclusions: Treatment with sofosbuvir?velpatasvir or sofosbuvir?velpatasvir?voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
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KEYWORD
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Direct-acting antiviral, Decompensated cirrhosis, NS5A inhibitor, Polymerase inhibitor, Protease inhibitor
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